JP2022520913A - New single-focus intraocular lens for refractory macular vision in patients with macular degeneration - Google Patents

Abstract

An intraocular lens system consisting of a single lens with two optical planes selected to maintain image quality in the fovea while reducing image aberrations at the preferred retinal loci outside the foveal region.

Description

(Cross-reference to related applications)
This PCT patent application claims priority benefit from US Provisional Patent Application No. 62 / 770,999 filed on November 23, 2018. The disclosure of such provisional applications, where appropriate for teaching additional or alternative content, features and / or technical background, is part of this specification by reference in its entirety, respectively. More priority is claimed.

The decades following the initial introduction of intraocular lenses (“IOL”) have focused primarily on obtaining optimal vision correction results for emmetropic individuals undergoing transparent lensectomy and cataract surgery. It was being killed. This led to the development of injectable soft acrylic IOLs designed to minimize postoperative astigmatism and aspheric lens optics to combat the positive spherical aberration of the cornea with age. Today, standard soft acrylic IOLs can project a well-focused image on the fovea, ensuring good vision correction results for patients with no other eye problems. .. However, the image quality obtained with such a lens is significantly degraded by only a few degrees off the center of the fovea, resulting in eccentric fixation due to the use of a healthy retina outside the central part of the fovea. It can have a significant impact on the results of vision correction in patients with macular disease, which is often the case. Eyes with age-related macular degeneration (hereinafter referred to as "AMD") have low contrast sensitivity and have a visual field scotoma (often including the central part), and are therefore particularly affected by deterioration of retinal image quality. Patients with macular disease with central lesions are expected to have poor visual quality using standard IOLs, coupled with reduced contrast sensitivity and photoreceptor patchy loss associated with pathological conditions such as AMD. In addition, as a condition such as AMD progresses, the patient suffers from poor quality of images projected onto the preferred retinal locus ("PRL") as the macula is further affected.

Surgical options for patients with macular disease undergoing cataract removal and IOL insertion are extremely limited. For now, surgeons aim for emmetropia, primarily using standard single-focus IOLs, and focus the image precisely in the fovea of the patient. However, the image quality obtained by a standard IOL is only 4 degrees retinal eccentricity (about 1.15) in this region, despite the relatively high cone density of about 20,000 / mm ² . mm) drops rapidly ¹³ .

Alternatives include the insertion of an intraocular telescope that provides a magnified image or the use of a prism device for a single PRL. Some devices use a combined approach. Because AMD patients often use multiple PRLs to perform activities of daily living, targeting a particular PRL impairs image quality at other retinal loci used in activities of daily living. There is a drawback that it is. Image optimization in one particular PRL can be completely wasted if the patient begins to rely on another PRL as the disease progresses.

The intraocular telescope has the optical advantage of magnifying the image in the eye, and is intended to improve the convenience of the handheld magnifying glass by eliminating the trouble of adjusting the hand and the eye. The device is relatively large and often complex compared to standard IOLs, making safe insertion difficult. The main drawback of intraocular telescopes is that the magnification causes a narrowing of the peripheral visual field. Depending on the device, the peripheral vision may be too narrow to be inserted into only one eye. In addition, the intraocular telescope distributes a limited amount of light over a wide area of the retina, so that the contrast of the obtained image is inevitably reduced. Therefore, both intraocular telescopes and prism devices correlate reading ability with both contrast sensitivity and fixative stability, which can impair the patient's innate ability to deal with central visual field defects and affect visual function. There is sex. Similarly, when the device is inserted into only one eye, the binocular addition effect is impaired, which affects the scanning of the entire macula image that occurs during reading and is likely to impair the reading function.

The invention described herein has a uniquely configured optical system that projects a focal image over the entire area of the macula from the fovea to a maximum of 10 degrees, and is a single, infusion that is inserted into the capsular bag. A possible soft polymer (eg, acrylic) IOL, which is an improvement over existing technology. The optical system is designed for patients with early-stage disease to maintain image quality in the center of the fovea. By correcting for optical aberrations that occur when the patient eccentrically fixes the degree of retinal eccentricity by up to 10 degrees, the IOL of the embodiment maximizes the potential for vision recovery in macular disease and progresses vision loss. Is to prevent. With such a new IOL, it is estimated that even with a target power of + 2D to + 3.5D, a magnification of 10 to 20% can be obtained with eyeglasses, but this is not an essential part of the operating principle.

In one embodiment of the invention, there is provided a single, injectable soft hydrophobic polymer (eg, acrylic) IOL designed for insertion into the capsular bag. The lens optics have been uniquely optimized to improve image quality anywhere within the macula, even with eccentric fixation of 0 to 10 degrees in any direction from the fovea. The lens of the embodiment exerts its effect in the case of a patient with eccentric fixative by forming it so as to minimize the optical aberrations that may occur in a standard lens. The lens of the embodiment has a radius and a conical constant that projects a focal image onto the fovea and reduces higher order aberrations over a region from focus to 10 degrees (but not necessarily limited to) in all gaze directions. Is designed to.

The new lens improves image quality with increasing retinal eccentricity compared to standard single focus IOLs and may be beneficial to patients with macular disease. One embodiment of the IOL can be used for postoperative refraction of hyperopia. With a target power of + 2D to + 3.5D, it is possible to obtain a magnification of 10 to 20% with eyeglasses. The purpose of postoperative emmetropia or myopia is to target individuals who are expected to improve their visual acuity, or to avoid postoperative anisometropia, as in the case of standard single focus IOL.

The IOL frequency of the embodiment is obtained with diopter frequencies 11, 13, 15, 17, 19, 21, 23 and 25 D, but the IOL of the embodiment is not limited to this range. The IOL power suitable for the individual eye can be estimated using the SRK / T formula (or similar) biometric method and the A constant 119.2, as well as the standard lOL inserted during cataract surgery.

One embodiment of the IOL has obvious advantages over existing intraocular telescopes in the treatment of macular disease. Intraocular telescopes such as implantable ultra-compact telescopes (hereinafter referred to as "IMT") and intraocular lenses for the visually impaired (hereinafter referred to as "IOL-VipTM") are relatively expensive and complex devices. The risk-benefit profile is less attractive due to the need for a large incision in the eye, narrowing of the visual field, risk of corneal endothelium compensation failure, and postoperative vision rehabilitation ^{11, 12} .

In one embodiment, the invention is a single, injectable soft polymer (eg, acrylic) IOL designed for insertion into the capsular bag, wherein the lens optics are up to 10 degrees from the fovea. The device constitutes a new type of IOL because it has been uniquely optimized to project a high quality image over the entire area of the macula.

As shown in Example 1, the lens improves image quality at higher retinal eccentricities compared to standard single focus IOLs and may be beneficial to patients with macular disease. Embodiments of the IOL of the present invention can also be used for postoperative refraction of hyperopia. For example, with a target diopter of +2.00 to +3.50 diopters, a magnification of 10% to 20% can be obtained with spectacles, but the degree of hyperopia depends on the severity of macular disease and the patient's preference or the suitability of the approach. Can change. The purpose of postoperative emmetropia or myopia is to target individuals who are expected to improve their visual acuity, or to avoid postoperative anisometropia, as in the case of standard single focus IOL.

In the embodiment, it consists of a lens with a first surface and a second surface, which improves the quality of the image over the entire area of the macula from the fovea to 10 degrees and improves the patient's visual acuity in the intraocular P diopter. Provides a lens system. The lens is defined as an optical portion diameter (D) and a center thickness (T). The first surface is a sphere with a first radius of curvature (hereinafter referred to as "R ₁ "). The second surface is a rotationally symmetric conical surface, has a second radius of curvature (hereinafter referred to as "R ₂ "), and is a function of radial coordinates (hereinafter referred to as "r"). (Coordinates) is given by the following equation.

In one specific embodiment, the preferred variables are P = 11 diopters, D = 6.00 mm, T = 0.7 mm, R ₁ = 19.99 mm, R ₂ = -143.7 mm, and k = -12.7. In another specific embodiment, the preferred variables are P = 17 diopters, D = 6.00 mm, T = 0.7 mm, R ₁ = 110.53 mm, R ₂ = -12.96 mm, and k = -12.7. In yet another specific embodiment, the preferred variables are P = 25 diopters, D = 6.00 mm, T = 0.7 mm, R ₁ = -45.52 mm, R ₂ from -6 mm to -19 mm, and k =-. It is 12.7.

Embodiments of the present invention will be described in the accompanying drawings below.

It is a schematic diagram of a design process.

It is an outline drawing of the IOL of 17 diopter frequency of one embodiment.

It is an outline drawing of the IOL of 19 diopter frequency of one embodiment.

It is an outline drawing of the IOL of 21 diopter frequency of one embodiment.

It is an outline drawing of the IOL of 23 diopter frequency of one embodiment.

It is an outline drawing of the IOL of 25 diopter frequency of one embodiment.

A standard single focus IOL projects a focal image onto the fovea. In patients with dry AMD, central sensory paralysis often results in loss of foveal functional visual acuity. However, if the patient is able to perform eccentric fixative, the surrounding macula still has sufficient receptor density / visual function to maintain functional vision.

The invention disclosed herein maintains the quality of the image in the fovea in the IOL of the embodiment, but is a standard single focus IOL when the eye is slanted due to eccentric fixative. It is designed to correct the optical aberrations that may occur in the case of. This optimizes the image quality in any region within 10 degrees of the fovea, facilitating the use of that region as a PRL and leading to improved post-insertion function. The purpose is to obtain a good retinal image up to an eccentricity of 10 degrees, and the image is magnified at low magnification when combined with spectacles to correct the refraction target up to + 3D.

The IOL design of this embodiment is an eye model (Liou-Brenan: Liou HL, Brennan NA. Anatomically accurate, finite model eye for optical modeling) that describes an average eye obtained from the literature. Optimal finite eye model). J Opt Soc Am A. 1997; 14 (8): 1684-1695.), Which can be performed using commercially available rate racing software (Zemax OpticStudio, Zemax LLC, USA). can. FIG. 1 is a schematic diagram of an embodiment of the design process.

Ray tracing techniques can be used to optimize the optical performance of different IOLs within the above eye models. Optical design software may be used (Zemax OpticStudio, Zemax LLC, USA). Further, after selecting the material, a merit function for designing the IOL of the embodiment may be created. In general, the parameters can be selected from those related to the performance of the lens of interest. In the optimization procedure, different values may be systematically given to the independent variables. These can then be used to calculate the selected merit function component. The purpose is to find a set of variable values that minimizes the merit function. Ideally, the procedure should be terminated by finding the global or absolute minimum, not the local minimum. The resulting merit function includes constraints on the geometric parameters of the IOL, which are kept within the physiologically compatible range. In this example, the variable parameters for optimizing were the thickness of the lens, the position of the lens within the capsule, the radius of curvature, and the asphericity of the different surfaces. Three configurations were simultaneously included in the merit function corresponding to incident beams with on-axis, horizontal eccentricity of 5 and 10 degrees.

特定の非限定的17Dバージョンのレンズの関連パラメータは、以下のとおりとする。
光学部径： 6.00 mm
中心厚： 0.7 mm
第1（前）表面：
標準球面
曲率半径110.53 mm
第2（後）表面：
回転対称円錐面。動径座標rの関数である面のサグ量（z座標）は、次式により与えられる。

特定のパラメータは、以下のとおり。
R = -12.96 mm
k = -12.7
上記値と単位から、zはmmの単位で計算される。 Each IOL of the embodiment has the following common features.
The front surface is a standard spherical surface having a range of curvature or a radius of curvature. The rear surface is a rotationally symmetric conical surface. The sag amount (z coordinate) of the surface, which is a function of the radial coordinate r, is given by the following equation.

The relevant parameters for a particular non-limiting 17D version of the lens are:
Optical part diameter: 6.00 mm
Center thickness: 0.7 mm
First (front) surface:
Standard spherical surface
Radius of curvature 110.53 mm
Second (rear) surface:
Rotationally symmetric conical surface. The sag amount (z coordinate) of the surface, which is a function of the radial coordinate r, is given by the following equation.

The specific parameters are:
R = -12.96 mm
k = -12.7
From the above values and units, z is calculated in mm.

The same eye model (Liou-Brennan cornea, axial length 23.5 mm) can be used as a reference for the standard IOL of the design, but instead of the IOL of the embodiment, the IOL is lighted onto the retina. We modeled the optimal diopter power required to focus on. For the eye model and the IOL position (the axial distance from the surface of the second cornea to the anterior surface of the IOL is also 4.16 mm), the index of refraction is spherical (radius of curvature is 27.51 mm and -14.59 mm on the anterior and posterior surfaces, respectively). A 21.5D IOL (immersed in a refractive index of 1.336) with a thickness of 1.54 and a thickness of 0.70 mm was used.

To assess the image quality of the IOL of the embodiment, a NIMO instrument (LAMBDA-X, Nivelles, Belgium), including an optical bench, is used with its software version 4.5.15. The operating principle of the device is based on the phase shift Schlieren technology ^{71, 72} . By combining the principle of Schlieren imaging and the phase shift method, it is possible to measure the ray deviation with NIMO equipment, and it is possible to calculate the wavefront analysis considering the Zernike coefficient of 36. It has been found that this technique can effectively measure the in vitro optical properties of IOLs. The equipment complies with the International Organization for Standardization (ISO) 11979-216. All IOL measurements were performed by immersing in saline (Laboratoires Sterop SA, Anderlecht, Belgium) having a composition equivalent to 0.154 milligrams per ml of sodium chloride. The cuvette or wet cell used to hold the IOL and saline in the proper position during the measurement has been validated by an interferometer and has been found to have a frequency of less than 0.005D. A separate cross-check of the wet cell was performed so that the measurement would not be disturbed. In addition, accurate frequency measurements are possible only if the setup is well calibrated. Therefore, the equipment was calibrated for each measurement.

In Example I described in detail below, the axial length of the eye model was set to 23.5 mm. The corneal parameters (curvature, asphericity, thickness and index of refraction) were taken from the Liou-Brennan eye model (see). The retina was simulated as a -12 mm sphere and the anterior surface of the IOL was placed 4.16 mm axially from the second surface of the cornea.

The spectacle lens was modeled using a lens with a refractive index of 1.585 (polycarbonate) and a center thickness of 5 mm, which was placed 12 mm (distance between vertices) from the apex of the cornea. The radii of curvature were 32 mm and 36 mm (+3 diopters) on the anterior and posterior surfaces, respectively. In addition, we simulated a + 6D spectacle lens with the same frontal curvature and a posterior radius of curvature of 44.7 mm (when the object was placed 33 cm from the cornea). All calculations were performed with a frequency of 550 nm and a pupil diameter of 3 mm.

The IOL lens of this embodiment was optimized for a refractive index of 1.54 (at 550 nm), an Abbe number of 40, and a thickness of 0.70 mm.

This optimization procedure was repeated for models with different specified axial length values. This provides lenses optimized for various powers. Figures 2-6 show the actual shape of the IOL in optimized embodiments of various frequencies. The corresponding emmetropic targets are shown below each lens. When using the setting and target of this method, for this non-limiting example, as the diopter power of the IOL increases, the curvature of the rear surface of the lens becomes stronger, while the sign of the curvature of the front surface changes from the positive curvature. It takes a flatter, then negative curvature value. This is the result of the shape factor optimization procedure for each model.
(Example 1)
Clinical trials

In order to evaluate the safety and initial outcome after the new IOL insertion, a clinical trial was devised and conducted in patients with binocular advanced AMD. Eight eyes of seven subjects with ≤1 cataract (not greater than 2 in the LOCS III classification), binocular progressive geographic atrophy / dry AMD and preoperative corrected distant visual acuity ≥0.60 (CDVA; LogMAR) Postoperative refraction target was used to perform lensectomy and IOL insertion. The target degree of postoperative hyperopia is sufficient with the patient for the magnification benefits that would be gained with spectacles when using this approach, while contrasting with the drawback of increased dependence of spectacles in activities of daily living. It was decided after discussion. In all cases, moderate to severe visual acuity deterioration was observed in the surgical eye, so we decided to set the postoperative hyperopia to 1.5D to 4.5D depending on the situation of each person (second if necessary). Includes consent to eye surgery.) Initial follow-up and evaluation were performed at baseline, 1 week, 1 month, and 2 months.

At baseline and at 1 week, 1 month and 2 months after surgery, subjective refraction, corrected near vision (with a near point of 30 cm, converted by LogMAR), corrected distance vision (LogMAR), intraocular pressure ( Goldman ocular tonometry), specular microscope (Nidek CEM-530, Nidek Co. Ltd .; 3 acceptable images obtained from central corneal), clinical examination, anterior ocular OCT (Visante, Carl Zeiss Meditec AG) ) And yellow spot OCT (Stratus OCT ^TM Carl Zeiss Meditec, Germany) were examined. Classification of lens opacity was performed based on the LOCSIll system. The visual field was evaluated by a threshold test of 80 points. In the surgical eye, after correcting the refractive error 1 month after the operation, the reading visual acuity, the critical character size and the reading speed were evaluated using the MNREAD chart. Microfield measurements were performed using the Macular Integrity Assessment (MAIA, Ellex Medical Lasers Ltd.) at baseline and 1 to 2 months postoperatively, and further microfields were performed at 1 to 3 month intervals to confirm any observed changes. Measurements and evaluations were performed. Microfield measurements were performed under mesopic conditions without mydriasis using an "expert" algorithm to assess macular threshold sensitivity and fixative stability (in the 10 degree region centered on PRL). 37 points tested; 4-2 strategy; size of stimulus with duration 200 ms Goldmann III). Exclusion criteria include treatment for active choroidal neovascularization (CNV) within 6 months of recruitment, axial length of> 24.5 mm or <20.5 mm, and uncontrolled glaucoma. Includes cases of intraocular surgery within 6 months after recruitment.

The average age of the patients was 77 ± 16 years (43-91 years), and the male-female ratio was 5: 3. Surgery was performed by one surgeon (MAQ) using standard techniques. A local mydriatic drug was used to dilate the pupil, and anesthesia was performed by subcapsular delivery of Tenon. Using a femtosecond laser surgery platform (LenSx ^(R) , Alcon ^(R) , FortWorth, Texas, USA), a 5 mm incision was made in the lens capsule and fragmented, and the WHITE STAR Signature ^(R) lens ultrasound suction system (Abbot Medical) was used. A standard 2.6 mm corneal incision was made at 100 degrees using Optics, Abbot Laboratories Inc. (Illinois, USA) and the lens was removed. The capsular bag was filled with aggregated ocular mucilage (OVD), the lens was loaded into an inserter, injected into the capsular bag through the main wound, the lens was centered, and the OVD and buffer salt solution were replaced. All subjects achieved postoperative equivalent spherical power within 1D of target diopter power (mean + 2.9 ± 1.3D).

result

With specular microscopy, the average rate of decrease in the number of endothelial cells after surgery was 13 ± 14% (0-37%). Two eyes showed a 37% and 31% decrease. This subject became unfollowable after 2 weeks, probably due to non-compliance with eye drop compliance. Other results were consistent with the predicted reduction ⁽ 4-13%) after cataract surgery with standard phacoemulsification8. The results of the 80-point visual field test were similar before and after surgery (the average observed score was 53 ± 27 after surgery and 50 ± 31 before surgery), and the anterior eye and macular OCT. The images showed that the IOL was well centered and the postoperative macula was stable. Postoperative intraocular pressure was stable for all subjects, and the mean intraocular pressure before and 2 months after surgery was 16 ± 2.8 mmHg and 14 ± 2 mmHg, respectively.

Postoperative MN reading data were not available for one subject. For others, the average reading visual acuity improved slightly from 1.07 ± 0.31 LogMAR to 0.9 ± 0.37 LogMAR, and the critical character size improved slightly from 1.04 ± 0.25 to 0.95 ± 0.27. The average reading speed increased from 28 ± 19 words per minute to 44 ± 31 words, with a 57% improvement.

Microfield measurement data were obtained approximately 1 and / or 2 months postoperatively in all but one of the target eyes. The threshold sensitivity measured by microfield measurement improved from 8.2 ± 4.6 dB on average to 12.0 ± 5.6 dB. The average percentage of solid viewpoints within the fourth-degree circle increased from 77 ± 17% to 91 ± 11%. For one subject, postoperative microvisual field measurement data was not available, but the subject's visual acuity after insertion was significantly improved. Microvisual field examination revealed slight changes in the 3 eyes after surgery, and other findings of gradual improvement were confirmed at 1 and 2 months.

Further microvisual field examinations were performed on 3 of the surgical eyes, and a gradual improvement in visual function was observed after the second month. PRL in these eyes was found to gradually move away from the geographic atrophy site. In the subject's first eye, the mean threshold sensitivity increased from 0 dB to 16.6 dB in 5 months, with a concomitant increase in the mean percentage of solid viewpoints within the 4 degree circle from 64% to 94%. .. In the subject's second eye, the mean threshold sensitivity dropped slightly from 4.2 dB to 3 dB on examination 4 months after surgery, but the mean percentage of solid viewpoints within the 4 degree circle was 57% to 93%. The fixation points were concentrated in the narrow path between the optic disc and the wide geographic atrophy site. At examination of the third subject four months later, the threshold sensitivity increased from 12.9 dB to 27 dB, and the average percentage of solid viewpoints within the fourth-degree circle decreased slightly from 99% to 83%.

No symptoms of unequal vision were reported, but all subjects later inserted the device into the other eye.

Postoperative visual acuity improvements consistent with laboratory simulation results were observed in moderate to severe AMD subjects, with an average improvement of 18 ETDRS characters in distance and near vision, and a 57% increase in average reading speed. The results are very good compared to the published outcomes after cataract surgery in AMD patients, including those who received CNV treatment. According to a recent meta-analysis, AMD subjects who underwent cataract surgery and had a standard single-focus IOL inserted could expect improved visual acuity of 6.5-7.5 ETDRS characters after 6-12 months of follow-up ^{9, 10} .

Description of Preferred Embodiment

The present invention is as described above, but those skilled in the art can make various changes and / or modifications to the present invention without departing from the gist and scope of the present invention described in the attached claims. It is easy to detect what can be done.
(Abbreviations and initials)
Age-related macular degeneration (AMD)
Bivariate contour ellipse area analysis (BCEA)
Confidence interval (Cl)
Corrected distance vision (CDVA)
Corrected near vision (CNVA)
Choroidal neovascularization (CNV)
Diabetic Retinopathy Early Treatment Study (ETDRS)
Transplantable Micro Telescope (IMT)
Intraocular lens (IOL)
Intraocular pressure (IOP)
LogMAR
Macular integrity assessment (MAIA) for acquiring eccentric vision
Eye mucilage (OVD)
Optical Coherence Tomography (OCT)
Preferred retinal locus (PRL)
Sample mean standard error (SEM)
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Claims (5)

With a lens that has a first surface and a second surface and provides P diopter power,
The lens is characterized by an optical portion diameter (D) and a center thickness (T).
The first surface is spherical with a first radius of curvature (R ₁ ).
The second surface is a rotationally symmetric conical surface, has a second radius of curvature (R ₂ ), and the sag amount (z coordinate) of the surface which is a function of the radial coordinates (r) is given by the following equation. ,

An intraocular lens system to improve the patient's eyesight. Claim 1 is characterized in that as the diopter power of the IOL increases, the curvature of the rear surface of the lens becomes stronger, while the sign of the curvature of the front surface changes from a positive curvature to a flatter one, and then a value of a negative curvature. Intraocular lens system as described in. The intraocular lens system according to claim 1, wherein the intraocular lens system is characterized by the following.
P = 11 diopters
D = 6.00 mm
T = 0.7 mm
R ₁ = 19.99 mm
R ₂ = -143.7 mm
k = -12.7 The intraocular lens system according to claim 1, wherein the intraocular lens system is characterized by the following.
P = 17 diopters
D = 6.00 mm
T = 0.7 mm
R ₁ = 110.53 mm
R ₂ = -12.96 mm
k = -12.7 The intraocular lens system according to claim 1, wherein the intraocular lens system is characterized by the following.
P = 25 diopters
D = 6.00 mm
T = 0.7 mm
R ₁ = -45.52 mm
R ₂ = -6 ~ -19 mm
k = -12.7

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